Nuvis IE4030
Nuvis IE4030 is a Class II device made by Integrated Endoscopy, Inc., cleared under FDA 510(k) K191594 on 11 Jul 2019 and listed in FDA GUDID since 30 Mar 2020 (UDI-DI 00853816008001), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00853816008001 | Date30 Mar 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191594 | Date11 Jul 2019 | StatusActive |
Official records
- AccessGUDID record 00853816008001
- FDA 510(k) database K191594
Across registries
- FDA 510(k) K191594 decided 11 Jul 2019 Active
- FDA GUDID UDI-DI 00853816008001 listed 30 Mar 2020 Listed
Timeline
- Cleared FDA 510(k) K191594
- Listed FDA GUDID 00853816008001
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Nuvis
- Generic name
- Rigid optical arthroscope, reusable
- Model / Ref / Catalog
- IE4030
- Primary DI / UDI-DI
- 00853816008001
- 510(k) Number
- FDA product code
- HRX
- GMDN term
- Rigid optical arthroscope, reusable
- Device class
- Class II
- Regulation number
- 888.1100
- GUDID distribution status
- In Commercial Distribution
- Size
- Angle — 30 degreeOuter Diameter — 4 MillimeterLength — 142 Millimeter
Similar devices in this category
Other devices filed under Rigid optical arthroscope, reusable.